Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435578
Recruitment Status : Terminated
First Posted : February 15, 2007
Last Update Posted : April 30, 2009
Information provided by:
Threshold Pharmaceuticals

Brief Summary:

The primary objectives of this study are:

  1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
  2. To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC

The secondary objectives are:

  1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
  2. To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)

The exploratory objectives of this trial are:

  1. To evaluate the effect of glufosfamide on lung cancer symptoms
  2. To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Lung Drug: Glufosfamide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma
Study Start Date : February 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Lung Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 years of age
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/IEC
  • Documented extensive SCLC with progression occurring at least 60 days after completion of first-line therapy (sensitive disease)
  • Measurable disease by RECIST criteria (at least one target lesion; no target lesion may have received radiotherapy within 6 weeks of study start)
  • A minimum of 21 days between prior radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
  • Recovered from reversible toxicities of prior therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,500/µL, platelets ≥ 100,000/µL
  • Total bilirubin ≤ 1.5-fold ULN
  • AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
  • Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
  • All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose

Exclusion Criteria:

  • More than one previous chemotherapy regimen
  • Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for SCLC other than protocol therapy
  • Limited stage SCLC (defined as confined to one hemithorax including ipsilateral supraclavicular lymph nodes and excluding pleural effusion)
  • Symptomatic brain metastases requiring corticosteroids
  • Active clinically significant infection requiring antibiotics
  • Known HIV positive or active hepatitis B or C
  • Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure, or stroke
  • Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
  • Major surgery within 28 days of the start of study treatment, without complete recovery
  • Females who are pregnant or breast-feeding
  • Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
  • Concomitant disease or condition that could interfere with the conduct of the study, or that, in the opinion of the investigator, could pose an unacceptable risk to the subject in this study.
  • Unwillingness or inability to comply with the study protocol for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435578

United States, California
California Cancer Center
Greenbrae, California, United States, 94904
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Threshold Pharmaceuticals
Principal Investigator: Gerold Bepler, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: John C Ruckdeschel, MD Barbara Ann Karmanos Cancer Institute
Principal Investigator: Peter D Eisenberg, MD California Cancer Center Identifier: NCT00435578     History of Changes
Other Study ID Numbers: TH-CR-304
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: April 30, 2009
Last Verified: April 2009

Keywords provided by Threshold Pharmaceuticals:
Recurrent Sensitive Small-Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents